Category Archives: Dermatology

New programs to make it easier and safer for San Francisco Bay Area residents to get rid of unused medications are some of the first to try this on a large scale, and may serve as models for other cities and counties.

Since May 2012, a pilot program in San Francisco has allowed residents to drop off old medications at 13 pharmacies and 10 police stations (where controlled substances must be brought). San Francisco supervisors initially considered forcing drug companies to fund the program, and instead agreed to accept $110,000 from Genentech and the Pharmaceutical Research and Manufacturers of America to fund the program.

(Photo by J. Troha, courtesy of National Cancer Institute)

On July 24, supervisors in Alameda County (which includes East Bay cities such as Oakland and Berkeley) are likely to approve a Safe Drug Disposal Ordinance that would require drug companies to pay for disposal of their products or face fines of up to $1,000 per day, The Bay Citizen reports. Public agencies currently fund 25 drug disposal sites there, and the cash-strapped county wants the comparatively wealthy pharmaceutical industry to take more financial responsibility for the lifecycle of its products in order to reduce overdoses, accidental poisonings, and water pollution.

As we reported earlier this year, making prescription-drug “recycling” a cultural norm is one of five emerging public policies that could help the medical system keep opioids available while reducing the risk of addiction, abuse and accidental overdose, according to Keith N. Humphreys, Ph.D. Smaller versions have met with success, such as a drug take-back day organized by sheriffs in a small town in Arkansas (population 20,000) that brought in 25,000 pills, said Dr. Humphreys, acting director of the Center for Health Care Evaluation, Veterans Health Administration, Menlo Park, Calif., and a professor of psychiatry at Stanford University. He reports having no financial conflicts of interest on this issue.

Not everyone is happy with the idea. Trade associations for the pharmaceutical industry and biomedical companies argue that there’s no evidence that these programs will reduce poisonings, and they haven’t ruled out the possibility of suing to block the Alameda County ordinance, The Bay Citizen reports. The compromise that San Francisco reached for voluntary instead of mandatory funding from the pharmaceutical industry may be a middle ground.

In an era when government agencies have less and less money for public programs, it’s probably inevitable that they’ll pursue alternative financing for programs like this.

If your community has a drug disposal program, let us know how it’s working. Will these programs succeed, and will they reduce abuse, addiction, and accidental overdoses? We’ll keep an eye on this topic, and keep you posted.

In advance of the upcoming XIX International AIDS Conference, the International AIDS Society and the University of California, San Francisco, have issued the “Washington D.C. Declaration,” a nine-point action plan aimed at broadening global support for “Turning the Tide” of the AIDS epidemic.

1) An increase in targeted new investments;
2) Evidence-based HIV prevention, treatment, and care in accord with the human rights of those at greatest risk and in greatest need;
3) An end to stigma, discrimination, legal sanctions, and human rights abuses against those living with and at risk for HIV;
4) Marked increases in HIV testing, counseling, and linkages to services;
5) Treatment for all pregnant and nursing women living with HIV and an end to perinatal transmission;
6) Expanded access to antiretroviral treatment for all in need;
7) Identification, diagnosis, and treatment of tuberculosis;
8) Accelerated research on new tools for HIV prevention, treatment, vaccines, and a cure;
9) Mobilization and meaningful involvement of affected communities.

Turning the Tide is the theme of this year’s biennial conference, which will take place July 22-27 in Washington. It is expected to draw 25,000 attendees, including HIV professionals, activists, politicians, and celebrities. Sir Elton John will open the conference and Bill Clinton will close it. A large delegation of U.S. members of Congress will participate, and Bill Gates will moderate a session. An enormous “Global Village” outside the D.C. Convention Center will be open to the public. “If you haven’t been, it’s a conference like no other,” conference cochair Dr. Diane V. Havlir said at a press briefing.

The recent optimism regarding HIV/AIDS stems from major advances in knowledge regarding prevention of partner transmission with early patient treatment, pre-exposure prophylaxis, and male circumcision as HIV infection prevention (new data will be released at the meeting), all of which are viewed as breakthroughs in the fight against HIV/AIDS. “So we have now in our hands the tools. The question is how do we combine those tools together, and how do we roll them out,” said Dr. Havlir, professor of medicine at the University of California, San Francisco, and chief of the HIV/AIDS division at San Francisco General Hospital.

Dr. Diane V. Havlir / Photo by Miriam E. Tucker

Monday’s plenary session will include an address from Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, on “Ending the HIV Epidemic: From Scientific Advances to Public Health Implementation.” Other plenary topics during the week will include viral eradication, vaccines, TB and HIV, and HIV/AIDS in specific populations including minorities, women, youth, and men who have sex with men. On Friday, there will be a plenary talk that may be of particular interest to the primary care community, “The Intersection of Noncommunicable Diseases and Aging in HIV.”

An innovative medical project that we reported in April has made the big time — a nationwide pilot program in the immense Department of Veterans Affairs system, the nation’s largest integrated health care system.

Project ECHO (Extension for Community Healthcare Outcomes) has been working wonders in New Mexico, Washington State, and a few other locations to bring specialty care to thousands of people who previously had little access to this care. Created by Dr. Sanjeev Arora of the University of New Mexico, Project ECHO connects primary care physicians with specialists in weekly case-management and educational teleconferences to give primary care physicians the support they need to manage complex patients with hepatitis C, asthma, chronic pain, rheumatic or cardiac disease, HIV, substance abuse, mental illness, high-risk pregnancy, childhood obesity, and more.

The U.S. Department of Health and Human Services awarded Project ECHO an $8.5 million Health Care Innovation grant in May 2012 to expand its operations in two states.

Impressed, the Department of Veterans Affairs cloned Project ECHO and tomorrow will launch a nationwide pilot program in the VA system that could help veterans get care in the local communities instead of traveling to specialists for treatment of heart failure, chronic pain, hepatitis C, etc. In our April 2012 video interview with Dr. Rollin M. Gallagher, deputy national program director for pain management in the Veterans Health Administration, he explains why Project ECHO is so appealing to the VA

The VA’s version, called Specialty Care Access Network-ECHO (or SCAN-ECHO), will kick off officially with a briefing by a panel of experts in Washington, D.C., that also can be viewed by Webcast (how appropriate) on Wednesday, July 11, 2012 from 10 a.m. to 11:30 a.m. Eastern time. Register here to view the Webcast.

The panel will feature Dr. Arora with Dr. Robert A. Pretzel, under-secretary for health in the V.A. system, Dr. John R. Lumpkin, director of the Health Care Group for the Robert Wood Johnson Foundation, which has funded much of Project ECHO’s work, and both specialty and primary care providers from the Cleveland VA Medical Center.

With any luck, the success of Project ECHO will echo across the country as this model of care expands.

Tumor necrosis factor inhibitor drugs began to dominate treatment of inflammatory diseases like rheumatoid arthritis, psoriasis, and the inflammatory bowel diseases ulcerative colitis and Crohn’s disease a little over a decade again. Now, the time when the importance of the anti-TNFs will wane and newer drugs will take their place is clearly visible on the horizon. It hasn’t happened yet, but the era of anti-TNF dominance for treating inflammatory diseases that persisted throughout the 2000s will end in the next 5 years.

The anti-TNF era began in 1998 with the approval of etanercept (Enbrel) for rheumatoid arthritis and infliximab (Remicade) to treat Crohn’s disease. In subsequent years, the list of approved anti-TNFs expanded to include adalimumab (Humira), golimumab (Simponi), and certolizumab (Cimzia), and the approved indications grew to include many inflammatory disease of joints, the GI tract, and skin. The anti-TNFs revolutionized inflammatory disease treatment and made treatment to remission possible for many patients.

But reports from just the past month show that new agents are overtaking the anti-TNFs.

In May, I reported from Digestive Disease Week on phase III trial results with vedolizumab, which was compared against placebo for patients with ulcerative colitis. One of the study investigators noted that vedolizumab beat the placebo arm for steroid-free clinical remission by 30 percentage points. “Nothing else is that good,” Dr. William Sandborn, professor of medicine and chief of gastroenterology at the University of California, San Diego, told me, and the benchmark he had in mind was the performance of the anti-TNFs in similar patients.

More recently, at the European Congress of Rheumatology earlier this month I heard a report on a head-to-head comparison of the anti-IL-6 drug tocilizumab (Actemra) and the anti-TNF adalimumab in patients with rheumatoid arthritis. After 24 weeks of monotherapy, patients on tocilizumab had nearly a fourfold higher remission rate than patients on adalimumab. Though the monotherapy trial design did not mimic the way most rheumatoid arthritis patients get treated, the new drug tocilizumab absolutely blew adalimumab out of the water in a rare head-to-head comparison among different classes of anti-inflammatory drugs.

And at the same meeting several talks highlighted another new anti-inflammatory class of agents coming soon to the U.S. market, the Janus kinase (JAK) inhibitors, such as tofacitinib, which is expected to received FDA approval later this summer. Phase III results show that tofacitinib has safety and efficacy that seems at least comparable to anti-TNF drugs, with the advantage of oral dosing.

Vedolizumab, tocilizumab, and tofacitinib are just the tip of new waves of anti-inflammatory drugs that will soon substantially alter a landscape that the anti-TNFs have mostly had to themselves for the past 14 years. For the moment, the anti-TNFs have the advantage of a longer track record for safety, but changing that is only a matter of time.

In the medical device arena, pre-market approval (PMA) submissions to the FDA keep taking longer and longer to process, according to Bob Rhatigan, senior vice president of facial aesthetics for Allergan Inc.

“A decade ago we used to see a PMA approval time of 9-12 months,” Mr. Rhatigan told attendees of the Summit in Aesthetic Medicine 2012. “In the middle of the last decade, that increased to 16 months, and as recently as 2010, that time frame is over 2 years. It’s something that we are anxiously watching. We don’t see any signs of that abating.”

The implications are gloomy for clinicians engaged in research of medical devices who wish to continue working in the United States. The current regulatory environment, Mr. Rhatigan said, “is working to push clinical research and studies outside of the U.S. market. It is not inconceivable, looking forward, to think about the bulk if not all of clinical research moving offshore as a result of companies like Allergan needing to get products approved more quickly. We are a bit pessimistic right now but [are] attempting to influence [legislators], as we want to make sure innovation in this industry continues to be ripe in the U.S. market.”

During the last presentation on the last day of the Summit in Aesthetic Medicine 2012, Dr. R. Rox Anderson shared some of his observations on creating change in the world of medicine. As the person who conceived of or helped develop many of the non-invasive treatments now widely used to remove birthmarks; microvascular and pigmented lesions; tattoos; and hair, he should know a thing or two about that topic.

“It takes people with passion,” Dr. Anderson, professor of dermatology at Harvard Medical School, Boston, said of change-leaders in medicine. “We’re driven to help other people. That is my primary passion. I go to work every-day thinking, ‘Science for the people.’ It’s also important to get very specific about the problem. I’ve noticed that the ability to really define the problem and own it is often where some of the passion comes from. Working on something that someone else told you about often does not sustain the process that you have to go through to make substantial change.”

Dr. Rox Anderson

Medical change-leaders exhibit unbridled curiosity mixed with health skepticism. “It’s interesting how change can happen if you mix people who are very problem-oriented with people who are very technology-oriented,” said Dr. Anderson, who also directs the Wellman Center for Photomedicine. “I kind of walk around with two bags: One of them you might label ‘Problems I care about but don’t know how to solve,’ the other one ‘Stuff I know about technology-wise.’ The challenge is to connect the two. I don’t know how that happens, but when it happens right, you get change.”

Change-leaders tend to be resilient, he said, explaining that real change is usually either threatening or surprising. “There’s a phrase, ‘You can tell the pioneers by the arrows in their backs.’ People are very uncomfortable with change. You will find that if you’re trying to put something new out there, you may threaten someone’s paradigm.”

In the business of medicine, he continued, “the bottom line is helping others. In medicine, if the problem isn’t about helping people, it’s going to fail. If you’re not curious and skeptical about something important, you’ll be off on some tangent that won’t ultimately make a tangible change.”

Strong commitment to the problem you’re trying to solve is essential, he said. He likened the level of commitment to a marriage in which you “Write a grant and start making phone calls to your colleagues, get a collaborative group together and say, ‘We’re going to attack this problem.’ Then you and the problem have ‘children’ – 3 or 4 ideas [of how to] solve the problem. Some of them work, some of them don’t. It’s the ones that don’t work that teach you things. My definition for bad research is that you can predict the outcome.

Should medical tattoos be standardized? Should there be guidelines pertaining to their design, and where on the body they’re located? Should physicians prescribe tattoos to patients with hidden medical conditions? And if the answer to any of those questions is yes, should medical personnel be the ones doing the tattooing?

Photo by Miriam E. Tucker / Used with permission

Those were among the questions raised by Dr. Saleh Aldasouqi in a poster presentation and at a press briefing at the annual meeting of the American Association of Clinical Endocrinologists.

Some patients with diabetes and other hidden medical conditions are choosing to be permanently tattooed rather than wear a necklace or bracelet to alert emergency personnel of their conditions. This is particularly common among patients with type 1 diabetes, for whom low blood sugar can result in unconsciousness or odd behavior that can easily be mistaken for drunkenness.

“There are a lot of patients with diabetes who are getting tattoos. Just Google ‘medical tattoos’ or ‘diabetic tattoos’ and you’ll find a large number from around the world. The problem is they’re not consulting their physicians. They could have high sugar, which can affect wound healing. …There are so many issues now being talked about with regard to medical tattooing,” noted Dr. Aldasouqi, an endocrinologist at Michigan State University, Lansing.

He believes these issues should be addressed by professional medical organizations, possibly including those pertaining to diabetes, dermatology, and emergency medicine.

As for tattoo location on the body, the wrist would be the most logical place since first responders will always check there, he said.

So who should do the tattooing? Tattoo parlors that are licensed under state or local laws are typically clean and use sterile equipment, and require customers to read and sign consent forms that address medical conditions and risks. Of course, tattoo artists would need to be educated about any new standard.

But dermatologists or plastic surgeons could do it as well. “We’re not competing with tattoo artists, but at least we can collaborate with them by standardizing at their level, or make it a minor surgical procedure. In fact, this is being done to mark the skin for radiation therapy in cancer patients, and in reconstructive surgery after breast cancer. Some medical tattooing is already being done by medical specialists. So, it’s open for discussion.”